BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR CUTTER RELOAD - STANDARD

    MDR report key: 2942353 · Received February 4, 2013

    Report

    Report Number
    3005075853-2013-00458
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). SWING TAB IN UNLOCKED POSITION. THE ANALYSIS RESULTS FOUND THAT THE CARTRIDGE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH NO INSTRUMENT. THE RELOAD WAS RECEIVED WITH THE 2 MOST PROXIMAL DRIVERS UP, AND THE SWING TAB IN THE UNLOCKED POSITION. IT SHOULD BE NOTED THAT AFTER THE STAPLE RETAINER HAS BEEN REMOVED, AN INADVERTENT MOVEMENT OF THE FIRING KNOB COULD CAUSE THE WEDGES TO MOVE FORWARD AND THEREFORE CAUSE THE STAPLES TO BECOME DISLODGED. THE CARTRIDGE WAS TESTED FOR FUNCTIONALITY WITH A TEST INSTRUMENT AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE INSTRUMENT FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABDOMINAL RECTOSIGMOIDECTOMY/ENTERORRHAPHY PROCEDURE, THERE WAS A DEFECT IN THE STAPLE LINE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46327 PROXIMATE** LINEAR CUTTER RELOAD - STANDARD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4C47G

    Patients

    Seq Age Sex Outcome Treatment
    1